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Completed

NCT Number: NCT00107965

Study to Determine the Safety of Two Applications of PEP005 Topical Gel to Actinic Keratoses

The purpose of this study is to determine whether topical application of PEP005 is safe for the treatment of actinic keratoses.

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Key information

Conditions

Actinic Keratosis Hyperpigmentation Keratosis Keratosis, Actinic Melanosis Neoplasms Pigmentation Disorders Precancerous Conditions Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Royal Prince Alfred Hospital, Sydney, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female patients
  • At least five individual AK lesions on the arms, shoulders, chest, face and/or scalp

Exclusion criteria

  • A cosmetic or therapeutic procedure:
  • within 10 cm of the selected AK lesions during the 3 months prior to study entry or
  • anywhere during the 4 weeks prior to study entry or anticipated treatment during the study
  • Treatment with 5-fluorouracil, imiquimod, diclofenac or photodynamic therapy:
  • of lesions located within 10 cm of the selected AK lesions during the 3 months prior to study entry or
  • anywhere during the 4 weeks prior to study entry or anticipated treatment during the study
  • Use of acid-containing products, topical retinoids or light chemical peels within 10 cm of the selected AK lesions during the 3 months prior to study entry, or anticipated treatment in this same area during the study
  • Treatment with immuno-modulators, cytotoxic drugs, or interferon/interferon inducers during the 4 weeks prior to study entry or anticipated treatment during the study
  • Treatment with psoralen plus UVA or use of UVB therapy during the 6 months prior to study entry or anticipated treatment during the study
  • Use of systemic retinoids during the 6 months prior to study entry or anticipated treatment during the study
  • Anticipated excessive or prolonged exposure to ultraviolet light or use of topical salves, creams or ointments to the selected AK lesions during the study
  • Females of childbearing potential

Treatment and study plan

PEP005

Drug

0.0025% PEP005 Topical Gel (Day 1,2 application)

Primary outcomes

  1. To determine the safety of PEP005 Topical Gel at 0.0025%, 0.01%, and 0.05% administered as two applications to patients with actinic keratosis (AKs) on the arms, shoulders, chest, face, and/or scalp

    Time frame: 85 days

Secondary outcomes

  1. To evaluate the efficacy of PEP005 0.0025%, 0.01% and 0.05% Topical Gel in treating Actinic Keratoses

    Time frame: 85 days

Sponsors and collaborators

Lead sponsor

Peplin

Industry

Registry information

Official study title

A Multi-center, Randomized, Double-blind, Parallel-group, Vehicle-controlled Study to Determine the Safety of PEP005 0.0025%, 0.01% and 0.05% Gel With Two Treatment Schedules, Day 1 & 2 or Day 1 & 8 Applications to Actinic Keratoses

Important dates

Study start
2005
Primary completion
2005
Study completion
2005
First posted
Apr 12, 2005
Registry last updated
Mar 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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